国家药典委拟制定药包材环氧乙烷测定法标准,为确保标准的科学性、合理性和适用性.
将“对照品溶液应连续进样不少于3次,所得待测物峰面积的RSD应不大于10%”修改为“对照品溶液连续进样5次,所得待测物峰面积的RSD应不大于10%”。
浩瀚色谱(山东)应用技术开发有限公司,根据药典标准,研制生产HH-624毛细管柱测定4209《药包材环氧乙烷残留》,乙醛不干扰,柱效高,结果满意。
名称:毛细管柱
固定相:6%氰丙基苯基94%二甲基聚硅氧烷
规格:60m×0.25mm×1.4μm
型号:HH-624
应用:4209 药包材环氧乙烷测定法

The National Pharmacopoeia Commission plans to develop a standard for the determination of epoxyethane in pharmaceutical packaging materials to ensure the scientific, rational, and applicable nature of the standard
The reference solution should be injected continuously no less than 3 times, and the RSD of the peak area of the analyte should not exceed 10% "should be modified to" The reference solution should be injected continuously 5 times, and the RSD of the peak area of the analyte should not exceed 10% ".
Haohan Chromatography (Shandong) Application Technology Development Co., Ltd. has developed and produced HH-624 capillary column for the determination of 4209 "Residual epoxyethane in pharmaceutical packaging materials" according to pharmacopoeia standards. Acetaldehyde does not interfere, the column efficiency is high, and the results are satisfactory.
Name: Capillary Column
Fixed phase: 6% cyanopropyl phenyl 94% dimethyl polysiloxane
Specification: 60m × 0.25mm × 1.4 μ m
Model: HH-624
Application: 4209 Determination of Ethylene Oxide in Pharmaceutical Packaging Materials
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